Guidance and regulation

Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 22 March 2023

• Crafting an intended purpose in the context of software as a medical device (SaMD)

  1.0 Introduction Failure to adequately define the intended purpose of a…

Statutory guidance on how NHS England should exercise the statutory functions that are intended to be transferred from NHS Digital.

• From: Department of Health and Social Care
• Updated: 23 May 2023

• NHS England’s protection of patient data

  Introduction and scope Introduction This guidance is issued by the…

Guidance for adult social care providers to comply with information provisions under Section 277A of the Health and Social Care Act 2012.

• From: Department of Health and Social Care
• Updated: 4 April 2024

• Adult social care provider information provisions: guidance for providers on data collection

  Background The COVID-19 pandemic exposed challenges in bringing together…

The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.

• From: UK Health Security Agency
• Updated: 16 October 2023

Formal notice for adult social care providers, setting out the information required by the Secretary of State under section 277A of the Health and Social Care Act 2012.

• From: Department of Health and Social Care
• Updated: 26 April 2024

Technical guidelines for healthcare professionals screening women at a higher risk of developing breast cancer.

• From: NHS England
• Updated: 4 January 2024

Funding to support local authorities in England in the dual running of the adult social care client level data (CLD) collection and Short and Long Term (SALT) return.

• From: Department of Health and Social Care
• Updated: 9 March 2023

Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 8 May 2024

Guidance for care providers and local authorities on What Good Looks Like (WGLL) for digital working in adult social care.

• From: Department of Health and Social Care
• Updated: 17 May 2023

Details and allocations of Department of Health and Social Care local authority-specific revenue funding for the financial year 2022 to 2023.

• From: Department of Health and Social Care
• Updated: 16 February 2023

Guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes.

• From: Medicines and Healthcare products Regulatory Agency
• Updated: 24 October 2023

A guide for designated operators of essential services for healthcare in England explaining the practical impact of the NIS Regulations.

• From: Department of Health and Social Care
• Updated: 27 September 2023

The NHS breast screening programme's specification for mobile breast screening units (MBSUs), also called mobile digital trailers.

• From: Closed organisation: Public Health England
• Updated: 1 October 2009

Evidence-based principles for the effective use of screening appointment text message reminders in reducing inequalities and supporting informed choice.

• From: Office for Health Improvement and Disparities
• Updated: 5 April 2022

This document sets out the NHS diabetic eye screening (DES) programme’s recommended cameras and settings for digital DES.

• From: NHS England
• Updated: 14 March 2024

A guide to good practice for the use of digital technology in health and care.

• From: Department of Health and Social Care
• Updated: 19 January 2021

Information on purchasing, installing, maintaining and the quality assurance of breast ultrasound scanners for the NHS breast screening programme.

• From: Closed organisation: Public Health England
• Updated: 30 April 2011

How developers can get their health app assessed and endorsed.

• From: Closed organisation: Public Health England
• Updated: 9 October 2017

Technical specification and associated documents for individual care accounts, allowing local authorities to monitor a person's progress towards the lifetime cap on care costs.

• From: Department of Health and Social Care
• Updated: 13 April 2023

Guidance on the enforcement process for adult social care providers who do not comply with information requests under section 277A of the Health and Social Care Act 2012.

• From: Department of Health and Social Care
• Updated: 21 July 2023